Course description
The QSIT (Quality System Inspection Technique) Training - FDA Audit Technique One-Day Course is designed to provide participants with a comprehensive understanding of the FDA's inspection process and the application of QSIT principles. This course focuses on equipping quality assurance professionals and regulatory affairs specialists with the knowledge and skills necessary to prepare for and manage FDA inspections effectively. Participants will learn how to navigate FDA requirements, conduct gap assessments, and implement corrective actions to ensure compliance with FDA regulations.
Benefits:
- Gain a thorough understanding of FDA inspection procedures and QSIT principles.
- Improve readiness and strategies for preparing organizations for FDA inspections.
- Enhance compliance with FDA regulations and quality system requirements.
- Network with industry peers and regulatory experts to exchange insights and best practices.
Upcoming start dates
Suitability - Who should attend?
Who Should Attend:
- Quality assurance managers, regulatory affairs professionals, and compliance officers in medical device and pharmaceutical companies.
- Consultants, auditors, and advisors involved in preparing organizations for FDA inspections and compliance audits.
- Professionals seeking to enhance their knowledge of QSIT principles and FDA audit techniques.
Outcome / Qualification etc.
Course Objectives:
- Understand the structure and objectives of FDA inspections and the QSIT approach.
- Learn the five subsystems covered by QSIT: Management Controls, Production and Process Controls, Corrective and Preventive Actions (CAPA), Device Packaging and Labeling, and Complaint Handling.
- Gain proficiency in conducting self-assessments and gap analyses to prepare for FDA inspections.
- Develop skills in documenting procedures and maintaining records to demonstrate compliance with FDA regulations.
- Understand the importance of quality system documentation and its role in FDA inspections.
- Discuss case studies and practical examples of FDA inspection experiences and outcomes.
Certification:
Participants will receive a certificate of completion upon fulfilling the course requirements, demonstrating their understanding of QSIT principles and FDA audit techniques.
Training Course Content
Morning Session:
- Introduction to FDA inspections: Objectives, scope, and regulatory framework.
- Overview of QSIT and the five subsystems: Management Controls, Production and Process Controls, CAPA, Device Packaging and Labeling, and Complaint Handling.
- Preparation for FDA inspections: Conducting self-assessments and gap analyses.
Afternoon Session:
- Documentation and record-keeping requirements for FDA inspections.
- Strategies for responding to FDA observations and implementing corrective actions.
- Case studies and practical examples: Applying QSIT principles to FDA inspection scenarios.
- Q&A session and knowledge assessment: Reviewing key concepts and addressing participant queries.
Course delivery details
Course Format:
- Duration: One day (8 hours)
- Delivery: Instructor-led training, available in both in-person and virtual formats.
- Interactive Learning: Case studies, group discussions, and practical exercises to reinforce learning.
- Comprehensive Materials: Participants will receive course handouts, FDA guidance documents, and a certificate of completion.
Expenses
Class Size and price: Up to 15 delegates £2,225.00
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